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PHARMACOLOGY

Pharmacodynamic

new type of "targeted" cancer treatment and an integral part of the body's immune system. Naturally the body build antibodies in along with to an antigen which has entered the body and attach to the antigen for destruction by the immune system. An essential cells only aimed by monoclonal antibiotics, they may leads to less toxicity to healthy cell and it is usually treatment recommended only for cancers in which antigens (and the respective antibodies) have been already identified. Ikgdar works by linking to the CD20 antigen on normal and malignant B-cells. Hence the body's essential immune security are initiated to attack and kill the marked B-cells. Stem cells i.eyoung cells in the bone marrow which will grow into the various cell types and do not have the CD20 antigen. After treatment,CD20 antigen allows healthy B-cells to multiply

PHARMACOKINETICS

Absorption: Not available Distribution: volume of distribution is 3.1 L Metabolism: Ikgdar 100mg metabolized by human antimurine antibody production. Elimination : not available The half life of NHL is 22 days and for RA is 18.0 days, GPA and microscopic polyangitis is 23 days.



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Brand : Ikgdar
Ingredients : Rituximab
Strength : 100mg
Manufactured : Emcure pharmaceuticals
Dosage form : injection

dosage management

Ikgdar is recommended to administer only through intravenous infusion not by IV push or bolus.

BEFORE EACH INFUSION PREMEDICATE

First infusion: initially rate of 50 mg/hr is given , in not showing infusion toxicity, rate raised upto 50 mg/hr increments at intervals of 30 min and max of 400 mg/hr. Successive infusion: 100 mg/hr initiated rate , in not showing infusion toxicity, rate raised upto 100 mg/hr increments at intervals of 30 min and max of 400 mg/hr. Premedication with corticosteroids must be considered, if Ikgdar combination with CHOP chemotherapy is not given.

LOW GRADE OR FOLLICULAR NON-HODGKINS LYMPHOMA

Dose is 375 mg/m2 as an IV infusion. Once weeks for 4 or 8 doses administrated for Relapsed treatment Relapsed Retreatment for once weekly for 4 doses administrated. Untreated Previously: given on day 1 of each cycle of chemotherapy, upto 8 doses. In complete or partial response of patient, start with 8 weeks for maintenance following Ikgdar in combination with chemotherapy completed then administer 8weeks for 12 doses as a single agent. Once weekly for 4 dose at intervals of 6 months and max of 16 dose for Non – progression (following CVP chemotherapy completion 6 – 8 cycles) On day 1 each cycle of chemotherapy upto 8 infusions for Diffuse large B- cell NHL.

COMPONENT OF ZEVALIN FOR TREATMENT OF NHL

Prior to the administration of Indium-111-(In-111-) Zevalin and Yttrium-90- (Y-90-)Zevalin administer Ikgdar infusion about 250 mg/m2 within 4 hours Before toRituxan and Y-90- Zevalin administrate Rituxan and In-111-Zevalin 7–9 days.

CHRONIC LYMPHOCYTIC LEUKEMIA

Before starting of FC chemotherapy, dose recommended is 375 mg/m2 followed 500 mg/m2 on day 1 of 2-6 cycles every 28 days.

RHEUMATOID ARTHRITIS

Ikgdar is administer with methotrexate combination Ikgdar administrating as two dose of 100mg IV infusion 2 weeks separated. When glucocorticoids administered as methyl prednisolone 100mg IV Subsequent course based on clinical evaluation should administer every 24 weeks, but not early than every 16 weeks.

GRANULOMATOSIS POLYANGITIS AND MICROSCOPIC POLYANGITIS

Weekly once for 4 weeks administer Dose of 375 mg/m2 IV infusion While Glucocorticoids combination with methylprednisolone by dose of 1000 mg IV/ day given for 1- 3 days and purse by oral prednisone 1 mg/kg/day are recommended for the treatment of symptoms of serious vasculitis . This drug should intiate within 14 days before or with the starting of Ikgdar 100mg and may continue during and after the 4 week course with treatment of Ikgdar 100mg drug. Safety and not established for subsequent infusion.

ADMINISTRATION

Take an Ikgdar amount and diluted to final concentration of 1 mg/ml upto 4 mg/ml as infusion (containing either 0.9% Nacl or 5% dextrose in water). Invert gently the bag and mix the solution. Dispose unused drug left in vial. OVERDOSAGE: If the patients had high dose of Ikgdar then seek immediately to the emergency department or poison control help line. Please consult the doctor for further clarification.

Common effects

fever and chills (flu lik symptoms)

Less common side effects

Weakness; nausea; headache; cough; dyspnae; pharyngitis



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drug interaction

Ikgdar 100mg drug interaction has limited data is available at present. Combination with fludarabine or cyclophosphamide has no effects in pharmacokinetics in CLL patients. Combination with methotrexate had no effects in pharmacokinetics.

CONTRAINDICATION

Hypersensitivity or murine proteins. Active severe infectons in rheumatoid arthritis Uncontrolled cardiac disease.

PRECAUTIONS

Allgeric condition against Ikgdar 100mg or any other medication informs your doctor. Concerning your past history of drug used which include in prescription, non-prescription, vitamins &supplements, nutritional products just inform the doctor. While using Ikgdar 100mg do not take any vaccination or immunization without taking advice from doctors. Avoid use of Ikgdar 100mg if you are pregnant. It will harm the baby unborn, while using Ikgdar 100mg use correct birth control to prevent pregnancy and for at least 2 weeks after your treatment ends. Ikgdar 100mg may affect the ability to have children in women. Inform your doctor if you planning to pregnant. It is unknown whether Ikgdar 100mg passes into breast milk , avoid breast-feed while on Ikgdar 100mg treatment.






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